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CINCINNATI CHILDREN'S, ABBOTT TO DEVELOP KIDNEY TEST
FDAnews - Sunday, August 13, 2006
Cincinnati Children's Hospital Medical Center has signed an exclusive agreement with Abbott Diagnostics to develop a test to detect kidney injury and ... more

NOVA SCOTIA MAN FIRST IN CANADA TO RECEIVE SURGICAL IMPLANT FOR CHRONIC BACK PAIN TREATMENT
FDAnews - Sunday, August 13, 2006
The Queen Elizabeth II Health Sciences Centre, the Faculty of Medicine at Dalhousie University and the Brain Repair Centre have announced the first successful surgery in Canada to implant the Precision Spinal Cord Stimulation (SCS) system, an advanced medical device that provides relief for patients living with chronic ... more

NUVASIVE ANNOUNCES IDE APPROVAL TO BEGIN NEODISC PIVOTAL TRIAL
FDAnews - Sunday, August 13, 2006
NuVasive, Inc., a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin clinical trial enrollment of its NeoDisc cervical disc replacement ... more

SMITH & NEPHEW AND Q-MED ENTER INTO STRATEGIC ALLIANCE IN OSTEOARTHRITIS TREATMENT
FDAnews - Sunday, August 13, 2006
Smith & Nephew Orthopaedics Trauma & Clinical Therapies and Q-MED AB today announced that they have formed a strategic alliance to develop and commercialize Q-MED's proprietary technology for the production of stabilized non-animal hyaluronic acid, NASHA for orthopedic ... more

Full Issue in PDF Format
FDAnews - Sunday, August 13, 2006
View the entire issue in PDF ... more

Baxter Healthcare Signs Consent Decree for cGMP Violations in Making Infusion Pumps
FDAnews - Sunday, August 13, 2006
Baxter Healthcare has signed a consent decree with the FDA related to violations of current good manufacturing practices (cGMPs) in making two brands of infusion pumps, the agency said June ... more

Storm of Regulatory, Legal Challenges Makes Boston Scientific an ‘Above Average’ Risk
FDAnews - Sunday, August 13, 2006
Saddled with mounting recalls, regulatory actions and lawsuitsrelated mostly to its recent acquisition of Guidant, Boston Scientific is an increasingly risky proposition for investors, a market analyst ... more

Industry Promotes Cost Savings of Devices, Diagnostics
FDAnews - Sunday, August 13, 2006
Lawmakers and government regulators need to consider the cost savings that devices and diagnostics offer to the U.S. healthcare system when making decisions that could affect patients’ access to new treatments, say industry leaders and at least one Senate ... more

ppeals Court Calls State DME Medicaid Policy ‘Unreasonable’
FDAnews - Sunday, August 13, 2006
A panel of the Eighth U.S. Circuit Court of Appeals June 22 overturned a ruling in a case where a Missouri policy denied Medicaid device coverage to most of the state’s adult program ... more

Debate Continues in Massachusetts Over Reprocessed Devices
FDAnews - Sunday, August 13, 2006
A bill under consideration in the Massachusetts state legislature offers patients the option of giving their informed consent before being treated with reused, or “reprocessed,” devices designed for single use ... more


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Device Industry Fully Engaged in U.S.-Korea Free Trade Negotiations
FDAnews - Sunday, August 13, 2006
An initial round of trade negotiations between the U.S. and South Korea in early June has “significant implications” for the device and diagnostics industry, AdvaMed said June ... more

German-Based EKSA Cited for QS, MDR Violations
FDAnews - Sunday, August 13, 2006
ESKA Implants was issued a May 16 warning letter for quality system (QS) and medical device reporting deficiencies that were uncovered during a November 2005 inspection of the company’s Lubeck, Germany, ... more

CDRH Drop in Warning Letters Cited As Lawmakers Blast FDA
FDAnews - Sunday, August 13, 2006
The FDA center responsible for monitoring devices and diagnostics may be slacking on enforcing agency regulations, a House lawmaker ... more

Briefs
FDAnews - Sunday, August 13, 2006
... more

ditor's Note:
FDAnews - Sunday, August 13, 2006
In observance of the Independence Day holiday, FDAnews Device Daily Bulletin will not be published Tuesday, July 4. The next issue will be published Wednesday, July ... more

MOUNTING COSTS OF FALSE CLAIMS A WAKE-UP CALL FOR INDUSTRY
FDAnews - Sunday, August 13, 2006
Government enforcement agencies are increasing their scrutiny of deceptive advertising practices in the marketing divisions of device and diagnostics firms, an FTC official said June ... more

J&J ACQUIRES PFIZER CONSUMER HEALTHCARE DIVISION
FDAnews - Sunday, August 13, 2006
Johnson & Johnson (J&J) is acquiring Pfizer's consumer healthcare division for $16.6 ... more

FDA PUBLISHES INFORMATION ON RECENTLY APPROVED FACIAL IMPLANTS
FDAnews - Sunday, August 13, 2006
The FDA has issued updated information Juvederm 24HV, Juvederm 30 and Juvederm 30HV gel implants, which were approved on June ... more

MITH & NEPHEW GETS SUBPOENAED BY JUSTICE DEPT.
FDAnews - Sunday, August 13, 2006
Smith & Nephew became the latest orthopedic-products maker on Friday to get a subpoena from the U.S. Department of Justice as an examination over potential violations of antitrust law ... more

NTEGRA LIFESCIENCES ANNOUNCES AGREEMENT TO ACQUIRE KINETIKOS MEDICAL, INC.
FDAnews - Sunday, August 13, 2006
Integra LifeSciences Holdings Corporation announced today that it has agreed to acquire the shares of Kinetikos Medical, Inc. ("KMI") for approximately $40 million in cash, subject to certain adjustments, including future payments based on the performance of the KMI business after the ... more

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